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Safety, Tolerability and Pharmacokinetics of Estetrol (E4) After Single and Multiple Oral Doses in Healthy Female Volunteers

NCT03075956 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2017-09-08

No results posted yet for this study

Summary

Estetrol (E4) is being developed in two indications supporting women health care: first E4 is combined with a progestin, \[drospirenone (DRSP)\] and is used as a new combined oral contraceptive (COC) for the prevention of pregnancy and secondly, E4 is used alone as new hormone replacement therapy (HRT) for the treatment of menopause related symptoms.

The current clinical trial is designed to collect more detailed information about the PK profile, safety and tolerability of different dosages of E4, given orally as a solid tablet.

Conditions

Interventions

DRUG

5 mg E4 single-dose

A single oral dose of 5 mg E4 will be administered during Period 1 of the study.

DRUG

15 mg E4 single-dose

A single oral dose of 15 mg E4 will be administered during Period 1 of the study.

DRUG

45 mg E4 single-dose

A single oral dose of 45 mg E4 will be administered once orally during Period 1 of the study

DRUG

15 mg E4 multiple-dose

15 mg E4 will be administered once daily orally for 14 consecutive days during Period 2 of the study

Sponsors & Collaborators

  • Estetra

    lead INDUSTRY

Principal Investigators

  • Dobrin Sviranov, Prof · Comac Medical

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2017-08-02
Completion
2017-08-02

Countries

  • Bulgaria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03075956 on ClinicalTrials.gov